MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYTEMS CORP. SARNS TEMPERATURE CONTROL AND MONITOR SYSTEM (TCM II); CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING

Model Number 4415

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Patient Involvement (2645)

Event Date 11/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The issue was discovered during cleaning.The user facility tried cleaning the hose connectors but the connectors were junked up.The flow was better after cleaning, but its not that good, and the flow was still low.They needed to get the unit fixed, and an fsr will repair the unit in field.Informed the fsr for repair.

Event Description

It was reported that during the use of the device for a non-clinical activity, the arterial flow volume was not good enough and flowing slow.There was no patient involvement.

Manufacturer Narrative

The field service representative (fsr) checked valve operation and verified low water flow.He found out-going hansen valve to be clogged with debris.The fsr cleaned hansen valve and inline filter of debris.The customer was advised to use cleaning protocol since unit has not been cleaned in some time using protocol.Copy of protocol was sent to the customer.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: SARNS TEMPERATURE CONTROL AND MONITOR SYSTEM (TCM II)
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7347416074
• MDR Report Key: 6160040
• MDR Text Key: 62380994
• Report Number: 1828100-2016-00785
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K883603
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4415
• Device Catalogue Number: 4415
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1